BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 3962578 · Received July 15, 2014

    Report

    Report Number
    1822565-2014-00861
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2008
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC., CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THE TREATMENT OF THE PATIENT. A REVIEW OF THE REVISION OPERATIVE NOTES INDICATED A TREMENDOUS AMOUNT OF SCARRING AND THE KNEE WAS VERY TIGHT IN FLEXION PARTICULARLY WHEN REMOVING THE ARTICULATING SURFACE IMPLANT. DURING THE REVISION, THE SURGEON NOTED THE ORIGINAL FEMORAL COMPONENT HAD BEEN INTERNALLY ROTATED COMPARED TO THE INTERCONDYLAR AXIS. THE FEMORAL COMPONENT SEEMED TO BE TRANSLATED POSTERIORLY BASED ON A FALSE ANTERIOR CORTEX CUT. THE FEMORAL COMPONENT WAS EASILY REMOVED WITH MINIMAL BONE LOSS. ZIMMER PACKAGE INSERT STATES PAIN AS A POTENTIAL ADVERSE EFFECT OF THE SURGICAL PROCEDURE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. IT IS UNKNOWN IF THE FALSE ANTERIOR CORTEX MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412729 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER INC 60254711

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention